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HHS/FDA RIN: 0910-AH47 Publication ID: Fall 2017 
Title: Revocation of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation 

This would revoke a regulation that accords new drug status to any drug sterilized by irradiation.   This would mean that FDA pre-approval would no longer be required for nonprescription drugs sterilized by irradiation that otherwise could be marketed legally without an approved new drug application (NDAA) or abbreviated new drug application (AN DA).  The technology of controlled nuclear radiation is better-understood than it was when the regulation FDA is proposing to revoke was promulgated, and since that time, appropriate and effective sterilization, including by irradiation, has been encompassed within the current good manufacturing practices (CGMP) requirements

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 371    21 U.S.C. 374    42 U.S.C. 264   
Legal Deadline:  None
Action Date FR Cite
Direct Final Rule  03/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Sudha Shukla
Health Science Project Manager
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 5198,
Silver Spring, MD 20993
Phone:301 796-3345